Review: Foundations of Clinical Research

Foundations of Clinical Research

This is a great summary of Clinical Research that I found particularly useful for the certifying exams given by the ACRP and SoCRA. And, I'm going to recommend it highly to my colleagues at the AAPP for preparation for their certifying exam.
You can purchase it for under $300 with CEU/CME credit from the Center for Clinical Research on their Web site.
Its contributing authors are some of the industry's best, including: Carol A. Saunders, R.N., President, Center for Clinical Research Practice; Alan M. Sugar, M.D., Professor of Medicine, Boston University School of Medicine and Medical Director, CCRP; Eileen Rusnak, Director, New Product Development and Institutional Relations, CCRP; Kimberly A. Hawkins, P.H., Consultant; Anna Demarinis, M.A., MA(ASCP)SBB, CQA(ASQ), Director of Regulatory Affairs, CCRP; and Karen L. King, Ph. D., Coordinator of the Clinical Research Certificate Program, Assistant Professor of Biology, University of Cincinnati, Raymond Walters College.
I had an opportunity to read the first edition of Foundations of Clinical Research years ago when I was new to clinical research and it gave me what I needed to jump start my research career. I found the revised second edition to be an independent study course designed to teach the basic principles and practices of clinical trials that has been expanded to include updated information about HIPAA Privacy Regulations, Federalwide Assurance requirements, ICH, and the National Bioethics Advisory Commission. In addition, a useful exercise on Source Documentation and CRF (Case Report Form) completion has been added that I particularly enjoyed.
When you order it, you will receive:

Textbook that covers the key issues and regulations affecting the day-to-day conduct of clinical research, a glossary of terms, bibliography, and section tests.
Workbook that includes 10 exercises using a sample Protocol, IB (Investigator's Brochure) and Case Study. It provides you the opportunity to apply the fundamentals learned in the Textbook to the practical application of a clinical trial.
Workbook Answer Key that provides a discussion of responses addressed in each exercise of the Workbook.
Medical Record and Source Documentation that includes samples of medical history and physical exam, lab and radiologic test results, progress notes and more. Using the data contained in the source documents, the learner completes an abbreviated Case Report Form (CRF).
Regulatory Reference CD that I do use at the beginning of new trials as we are designing the informed consent forms. It contains: Guiding Principles; Federal Regulations; ICH Guidelines for Good Clinical Practice; FDA Guidance; and FDA Compliance Programs.

Foundations of Clinical Research has helped me understand many concepts of clinical research better thru its highlighted key words, concepts and quizzes at the end of each chapter. The appendices were useful to: highlight differences between the FDA and HHS; define the sponsor's role in the IND 1571 form (21CFR312) and exactly what we are attesting to when the PI signs the 1572 form. It provided me with the historical perspective of what errors were made in the past and what is needed to prevent repeating them in my pharmaceutical medicine research practice today. I recognize that I will be able to enroll more research subject volunteers in more clinical trials quicker, ensuring their safety and welfare more than ever before, while making sponsors and the Agency pleased with clean data that's easily verifiable now. I think this is a key book for both the new and the seasoned PI to read in order to augment your understanding of the foundations of clinical research, to provide the skills to run a better research facility and the knowledge to pass certifying exams.

Sincerely,

Melody I. Sanger, BSN, RN, MD, CCRC, CCRP
Director of Clinical Research
Drug Study Institute
MSanger@DrugStudy.MD

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